Coopercompanies
From Coopercompanies's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Job Summary
Continuously improves the performance of existing manufacturing processes and equipment through a structured approach.
1. Coordinating production improvements implementation
2. Creating troubleshooting guidelines and/or applicable SOPs and equipment maintenance and repair
3. Identifying possible causes of variation/ failure/ under performance for Manufacturing.
4. Document diagnostics, solution method and impact in troubleshooting for Manufacturing.
5. Measuring Process KPIs for improvement
6. Analyzing through a structured approach to identify root causes
7. Improving Process KPIs performance
8. Developing control mechanism to ensure Process KPIs consistency
9. Designing and Coordinating Engineering Tests/ Q's
10. Executing Engineering Tests/ Q's
11. Documenting and Reporting Results of Engineering Tests/ Q's
12. Assuring Readiness of Manufacturing Requirements for the Product Transfer
13. Receiving and Implementing Product and Equipment Transfer
14. Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer
15. Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations
16. Implementation of Optimization Efforts
17. Defining Manufacturing equipment maintenance requirements
18. Developing TPM/ PM/ PDM procedures for Manufacturing Equipment
19. Verifying TPM/ PM/ PDM tasks effectiveness in Manufacturing.
20. Ensuring correct resources are acting upon situation for Equipment Repair
21. Correcting troubles in Manufacturing under performance situation using troubleshooting guidelines and/or applicable SOPs
22. Measuring Equipment Efficiency
23. Identifying Opportunities for Improvements in Equipment Performance
24. Implementing Equipment Upgrades and Optimization Changes
25. Writing Validation Documentation and Test Protocols
26. Documenting all Equipment Changes
27. Assuring Compliance with Laws & Regulations
28. Generation of Purchases Requisition
29. Submitting Scope and Approve Projects
30. Submitting Documentation for Safety Compliance, New Equipment Calibrations, Calibration extensions and Preventive Maintenance
31. Systems & Equipment PM's SOP's Revisions/ Improvements
32. Evaluating Needs for Infrastructure Projects and Start-ups
33. Submitting MSDS as Required
1. Supply Chain Performance Indicators Improvement
2. Unit RM Usage Optimization
3. Unit MRO, Incl. Spare Parts Usage Optimization
4. Quarterly Capex meeting with Projects and Owners Team
5. Defining Tactics for Quality First Pass, DPM & CPM Metric (Once a Year)
6. Quality Documentation Approval
7. Quality Awareness
8. Identifying and Implementing Corrective/ Preventive Actions
9. Preparing Rework Protocols or memos for NCRs
10. Investigating NCR, Quality Feedback and Complaint
11. Developing Actions to improve Quality KPI's
12. Developing Procedures for QI
13. Providing Training for QI
14. Providing Support for the QI Start-up
15. Defining and Prioritizing Process KPIs for improvement
16. Writing validation documentation (protocols)
17. Protocol Approval
18. Developing process and regulatory documentation for automation systems
19. Performing and documenting engineering studies
20. Early Involvement in Transference Effort with Technical Innovations (ROI)
21. Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer
22. Early Involvement in LS /Optimization Efforts with Technical Innovations (ROI)
23. Assuring Readiness of Manufacturing Requirements for the Optimization Efforts
24. Identifying possible causes of variation/ failure/ under equipment performance for Manufacturing.
25. Procedure Approval for skills certifications
26. Technical Academy design and delivery
27. Optimizing Unit Performance
28. Shutdown Planning and Execution
29. Inserts Inventory Supplies
30. Unit MRO, Incl. Spare Parts Price Optimization Awareness
31. Unit MRO, Including Spare Parts Inventory Optimization
32. Plant RM & MRO Leverage Opportunities
33. Unit Capacity Utilization $'s
34. Cost Modeling for Process Improvement
35. Material Quality issues avoidance
36. Monitoring Supplier's Performance
37. Evaluating Quality Issues Reports at Manufacturing. & QA Final
38. Investigation (Data gathering of Quality issue)
39. Evaluating NCR Actions Effectiveness
40. Initiating Non-Conformance Resolution
41. Evaluating NCR
42. Leading Improvement Activities
43. Developing supporting Documentation for QI
44. Implementing Safety corrective actions
45. Safety Non-Conformance Resolution
46. Identifying process and/or Manufacturing equipment not performing as expected
47. Ensuring correct resources are acting upon situation for Manufacturing
48. Designing and programming of Process automation improvement systems
49. Providing technical solutions that increase utilization and reduce costs
50. Improving accuracy Automation System requirements and specifications for the development of SCADA and other systems
51. Reviewing/ Modifying Standard Operating Procedures for Engineering Controls
52. Final selection of resources
53. Test Design for skills Certifications
54. Preparing Training Module for skills certifications
55. Budget Development and Administration
56. Monitoring Unit Performance
57. People Development
58. Providing Capabilities to Work Unit
1. Knowledge of FDA current GMP/QSR regulation
2. Excellent oral and written communication skills in both English and Spanish languages
3. Teamwork and service oriented
4. Effective leadership
5. Computer literate (PowerPoint, Word, Excel)
6. Willing to Travel
7. Excellent interpersonal skills
8. Highly Motivated, self-starter and responsible person
Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature
Needs to stand, walk, and may be seated for a long period of time
Uses hands to feel, handle and reach
Works with a personal computer and programs to prepare documents or reports
Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others
Needs to have high analytical capacity and level of professionalism and judgment to resolve problems
May be exposed to fumes, gases, or strong odors (non-toxic)
Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable)
University bachelor’s degree in engineering or advanced student in that fields (Industrial, Chemical, Mechanical, Electrical)
University master’s degree in engineering (Industrial, Chemical, Mechanical, Electrical) preferred
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